“23andMe has been giv­ing con­sumers ac­cess to health in­form­a­tion for six years and is com­mit­ted to find­ing the right reg­u­lat­ory path for our cus­tom­ers,” CEO and founder Anne Wo­j­cicki wrote in a state­ment on the com­pany web­site Thursday. “I am highly dis­ap­poin­ted that we have reached this point and will work hard to make sure con­sumers have dir­ect ac­cess to health in­form­a­tion in the near fu­ture. Our goal is to work co­oper­at­ively with the FDA to provide that op­por­tun­ity.”

The goal of 23andMe is to provide con­sumers with dir­ect ac­cess to their ge­net­ic in­form­a­tion in an easy and af­ford­able way. A test can be pur­chased on­line for $99, and provides re­ports on 254 dif­fer­ent con­di­tions and dis­eases.

However, the FDA ex­pressed con­cerns that the com­pany was selling its product as a dia­gnost­ic test for health risks. The agency said 23andMe must gain gov­ern­ment au­thor­iz­a­tion be­fore con­tinu­ing to mar­ket the product as a med­ic­al test.

The com­pany will con­tin­ue to provide an­ces­try in­form­a­tion and raw data to con­sumers, but will put the sale of health-re­lated res­ults on hold.

In­di­vidu­als who pur­chased ge­net­ic test­ing kits pri­or to when the FDA let­ter was sent on Nov. 22 will con­tin­ue to have ac­cess to their full res­ults. Those who pur­chased them on or after that date will only re­ceive an­ces­try in­form­a­tion and raw data, and will be eli­gible for a re­fund.

Wo­j­cicki em­phas­ized that the com­pany stands by their data, not­ing that the samples are sent to CLIA cer­ti­fied labs — the same stand­ards used for most health-re­lated tests.

“The in­form­a­tion 23andMe provides is in­cred­ibly ac­cur­ate,” 23andMe spokes­wo­man Cath­er­ine Afar­i­an told Na­tion­al Journ­al in early Novem­ber. “If we tell you you’re a C-C there, you are. From there, the next step is in­ter­pret­a­tion — what does sci­ence know about it?”

This is where the res­ults be­come less clear.

As Na­tion­al Journ­al pre­vi­ously re­por­ted, there is a sig­ni­fic­ant amount of un­cer­tainty re­gard­ing the in­ter­pret­a­tion side of these test res­ults. The con­cern is that in­di­vidu­als may make im­port­ant med­ic­al de­cisions based on res­ults that are con­stantly chan­ging and that even ex­perts don’t com­pletely un­der­stand.

The com­pany will con­tin­ue to move for­ward with the FDA’s reg­u­lat­ory re­view pro­cess, and hopes to re­sume of­fer­ing health-re­lated in­form­a­tion shortly.

Sen. Joe Manchin (D-WV) and Sherrod Brown (D-OH) are threatening to block the spending bill—and prevent the Senate from leaving town—"because it would not extend benefits for retired coal miners for a year or pay for their pension plans. The current version of the bill would extend health benefits for four months. ... Senate Majority Leader Mitch McConnell (R-KY) on Thursday afternoon moved to end debate on the continuing resolution to fund the government through April 28. But unless Senate Democrats relent, that vote cannot be held until Saturday at 1 a.m. at the earliest, one hour after the current funding measure expires."

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PARLIAMENT VOTED 234-56

South Korean President Impeached

1 hours ago

THE LATEST

The South Korean parliament voted on Friday morning to impeach President Park Geun-hye over charges of corruption, claiming she allowed undue influence to a close confidante of hers. Ms. Park is now suspended as president for 180 days. South Korea's Constitutional Court will hear the case and decide whether to uphold or overturn the impeachment.

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CLOSED FOR INAUGURAL ACTIVITIES

NPS: Women’s March Can’t Use Lincoln Memorial

1 hours ago

THE DETAILS

Participants in the women's march on Washington the day after inauguration won't have access to the Lincoln Memorial. The National Park Service has "filed documents securing large swaths of the national mall and Pennsylvania Avenue, the Washington Monument and the Lincoln Memorial for the inauguration festivities. None of these spots will be open for protesters."

Source:

2.1 PERCENT IN 2017

President Obama Boosts Civilian Federal Pay

1 hours ago

THE LATEST

President Obama on Thursday announced a pay raise for civilian federal employees of 2.1 percent come January 2017. He had said multiple times this year that salaries would go up 1.6 percent, so the Thursday announcement came as a surprise. The change was likely made to match the 2.1 percent increase in salary that members of the military will receive.

Source:

SHUTDOWN LOOMING

House Approves Spending Bill

20 hours ago

BREAKING

The House has completed it's business for 2016 by passing a spending bill which will keep the government funded through April 28. The final vote tally was 326-96. The bill's standing in the Senate is a bit tenuous at the moment, as a trio of Democratic Senators have pledged to block the bill unless coal miners get a permanent extension on retirement and health benefits. The government runs out of money on Friday night.